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CompletedNCT07545551DPBSPUpdated Apr 22, 2026

Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss

An interventional study of Supportive Care in Perinatal Loss, Grief and Depression Anxiety Disorder, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Apr 2025, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This study aims to evaluate the effectiveness of a digital perinatal bereavement support program designed for women who have experienced pregnancy loss. Perinatal loss is associated with significant psychological distress, including grief, depression, and anxiety, which may persist over time if not adequately addressed.

The intervention consists of a structured digital support program delivered over five weeks, focusing on emotional processing, coping strategies, and psychological resilience. Participants were assessed at baseline, immediately after the intervention, and during follow-up periods at 1 month, 3 months, and 6 months.

The primary objective is to determine whether the intervention improves psychological outcomes, including grief and depressive symptoms. The findings are expected to contribute to the development of accessible and scalable mental health support models for women experiencing perinatal loss.

Read the detailed description

Perinatal loss is a significant life event that can lead to long-term psychological consequences, including prolonged grief, depression, and anxiety. Despite the high prevalence of these outcomes, access to structured psychological support remains limited, particularly in scalable and accessible formats.

This study investigates the effectiveness of a digitally delivered perinatal bereavement support program developed to provide structured emotional and psychological support for women following pregnancy loss. The intervention was administered over a five-week period and included components targeting grief processing, emotional expression, and adaptive coping strategies.

Participants were evaluated at multiple time points, including baseline (pre-intervention), post-intervention, and follow-up assessments at 1 month, 3 months, and 6 months. Psychological outcomes were assessed using validated measurement tools.

The primary aim of the study is to assess changes in psychological outcomes over time and to determine the sustainability of intervention effects during the follow-up period. This study contributes to the growing body of evidence supporting digital mental health interventions and offers insights into scalable support mechanisms for perinatal bereavement.

02

Conditions studied

  • Perinatal Loss
  • Grief
  • Depression Anxiety Disorder

Keywords

  • perinatal beriavement
  • pregnancy loss
  • digital invertion
  • pylchological support
  • grief counseling
  • maternal mental health
03

In context

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

- Women aged 18 years and older who have experienced perinatal loss within the past two months; ability to read and write at a basic level; ability to speak and understand Turkish; access to a digital platform (internet-enabled device); and no history of previous live birth. Provision of informed consent.

Exclusion criteria

Exclusion Criteria:

History of a previous perinatal loss; presence of any uncontrolled psychiatric disorder; presence of communication impairments (cognitive, auditory, or visual); experiencing another major grief event (e.g., divorce, death) within the past year; or receiving any psychosocial support within the past year.

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    intervention group

    Participants received a structured supportive care program following perinatal loss. The intervention was delivered over a 5-week period and included psychological support aimed at reducing grief, anxiety, and depression.

    Behavioral: Supportive Care

  • No intervention
    control group

    Participants received routine postpartum care without any additional structured supportive intervention.

Interventions

  • BehavioralSupportive Care

    A structured supportive care program designed for women experiencing perinatal loss. The intervention was delivered over 5 weeks through a digital platform specifically developed for this study. It included regular psychological support sessions aimed at reducing grief, anxiety, and depressive symptoms. The program incorporated emotional support, coping strategies, and guided communication techniques.

06

What researchers measure

Primary outcomes

  1. Change in grief levels

    Change in grief levels measured using a validated grief scalesamong women experiencing perinatal loss, comparing the intervention and control groups.

    Time frame: Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up

07

Study locations

1 site
  • Gazi University Institute of Health Sciences
    Ankara, Ankara 06000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to ethical restrictions and the sensitive nature of psychological data collected from participants experiencing perinatal loss. Data confidentiality and participant privacy will be strictly maintained in accordance with institutional review board (IRB) approvals and applicable regulations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07545551
Lead sponsor
Gazi University
Collaborators
Gazi University Scientific Research Projects Unit (BAP) Project No: TDK-2026-10810
Responsible party
Şengül Yaman Sözbir (Professor, Department of Obstetrics and Gynecology, Gazi University) — Principal investigator
First posted
Apr 22, 2026
Start date
Apr 1, 2025
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025
Last update
Apr 22, 2026

Study contacts

Şengül YAMAN SÖZBİR, PhD
principal investigator · Gazi University
Büşra Özer, PhD Candidate
study chair · Gazi University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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